Wendy Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors and other ancillary providers in the health care life sciences space. She counsels clients regarding the research, manufacture, sale, promotion, distribution, pricing and import/export of pharmaceuticals, biologics and medical devices; government health care program compliance risks; drafting and negotiating co-promote agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements and third-party vendor arrangements; conducting health regulatory due diligences; defending pharmaceutical manufacturers in all phases of government investigations and inquiries; and counseling third-party payors in connection with the delivery of outpatient prescription drug benefit and specialty drug benefit programs offered under insured (commercial and government) and self-insured products. More
Natasha Leskovsek advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on FDA regulatory and clinical development matters. She also conducts regulatory diligence on behalf of entities investing in FDA-regulated companies. More
Philip Mitchell provides health regulatory counsel to a range of industry clients, including hospital systems, provider practice groups, management services organizations, clinical laboratories, managed care organizations and health insurers, pharmaceutical and biologic manufacturers, and specialty pharmacies, other proprietary and nonprofit health care enterprises, and investment firms. More
Sarah diFrancesca’s practice focuses on fraud and abuse, compliance, and regulatory issues within the pharmaceutical, medical device, and biotechnology industries. Her experience includes representing health care entities in connection with federal and state government investigations, inquires, settlements, and voluntary disclosures. More
Vince Sampson focuses on helping clients predict, navigate and understand the increasingly complex involvement of federal agencies and Congress in the regulation of health care, life sciences medical device industries. More
Robert Paster’s practice focuses on fraud and abuse, regulatory and compliance issues, as well as corporate guidance, within the healthcare, pharmaceutical and medtech industries.
Amy Westergren provides health regulatory counsel to clients in healthcare, the life sciences, and digital health. Amy’s practice ranges from advising clients on the state and federal regulatory requirements impacting their businesses to providing regulatory support on public offerings and private equity transactions. More